The FDA or the Private Sector: Who Should Take Responsibility for Supply Chain Security?

Over on Pharmaceutical Technology's blog, there's a good post that examines the debate over whether the public or private sector should take the lead when it comes to supply chain security. This is a topic that even those outside of the pharma business should give serious consideration to. In fact, any organization dealing in consumer (or even industrial/building) products should think twice about. In the life-sciences center, the current debate centers around the proposed 346 FTE ramp-up and $166 million overall budget increase the FDA is attempting to make to target the "globalization of manufacturing and supply of medical products". The hope, it seems, is that with better regulation and oversight, we can avoid patient fatalities and illnesses of the type caused by tainted Heparin from China years back. But who should take responsibility first and foremost? The public or private sector.

Ultimately, one of the great things about the US system of government and law are the multiple checks and balances on both the public and private sectors. Just as the power in the legislative branch is held in check by the executive and judicial ones, so too is the private sector ultimately held in check not just by legislation but also by potential customer litigation. But the problem is that litigation does not always preventatively address the issue of supply chain security. Rather, it is often a underlying symptom in a patient who needed proactive treatment in the first place.

The Pharmaceutical Technology post quotes from Pfizer's head of Global Manufacturing that "Supply chain security is the responsibility of all parties involved in procurement/ sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product". But the FDA also believe it must play a greater role in security as well. A new FDA study suggests that the agency's new plan must focus on implementing "new approaches and conduct new activities to effectively regulate the supply chain". Specifically, "the priorities proposed in this initiative will assure the safety and security of foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain, including their eventual use by American consumers".

As a consumer, I hope that both private sector organizations and the government regulatory agencies overseeing them begin to take more aggressive steps to police the global drug supply chain. But as important, let's hope that other industries outside of the purview of the FDA begin to consider similar measures and programs as well. After all, global supply chain security is everyone's problem. And when it comes to consumer products that we either ingest or must live with (e.g., tainted Chinese drywall) that can make us sick, we'll all be the better for more aggressive public and private sector vigilance and action.

Jason Busch

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